With the addition of electronic trial master file (eTMF) document storage, Pharmaseal is offering the capability along with clinical trial management software (CTMS) capabilities in one integrated platform. According to the company, the combination of the two in one place provides users with a higher level productivity.
Ricky Lakhani, director of product management at Pharmaseal, said because clinical trial operations and needs have evolved in recent years, technological solutions available to the industry should keep pace.
“With the added benefit of eTMF document storage, you don’t have to choose between two systems,” he said. “CTMS is the ‘brain’ and eTMF the ‘memory’ enabling users to know what’s happening in the process at all times via a consolidated standalone solution.”
Daljit Cheema, founder and CEO of Pharmaseal, said good clinical practice guidelines dictate that organizations should work to implement procedures and solutions that assure the quality of all aspects of trial operations.
“We thought, imagine if CTMS and eTMF capabilities were combined to support clinical operations processes and the associated documents in order to manage and track anything a study demands, within the framework of an easy to use, secure, validated enterprise platform,” he said. “Companies wouldn’t have to choose between separate systems with increasing IT costs and information fragmentation."
Cheema added that the Engility platform is designed to improve information consolidation, collaboration and the ability to operate trials with optimal oversight.
A TMF stores essential trial documents that are subject to regulatory oversight. According to Pharmaseal, an eTMF can help organizations better manage such crucial documents, and an integrated eTMF can further improve communication and connection.
Introduced last year, the Engility is intended to offer trial teams centralized data to study management, flexible monitoring, issue management, investigator payments, site and contract management, and eTMF document storage. This design, according to the company, reduces data duplication, removes the need to integrate disparate systems and increases overall trial oversight and governance.